GI Windows, Inc. · Class II · Cleared Jan 9, 2026
| K-number | K253550 |
| Device name | Self-Forming Magnet (Flexagon Plus OTOLoc) |
| Applicant | GI Windows, Inc. |
| Product code | SAH |
| Device class | Class II |
| Decision date | Jan 9, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4816 |
The Flexagon Plus OTOLoc System is a magnetic compression anastomosis device used to create side-to-side connections between loops of small intestine (jejunum-jejunum or ileum-ileum) during minimally invasive laparoscopic surgery. The magnetic components compress opposing tissues, allowing the body to naturally remodel and heal the tissue. Once the connection is formed, the device is naturally expelled from the body in approximately 3–6 weeks. It is intended for use in adult patients over 21 years old.
The subject device employs identical Flexagon and OTOLoc implant components as the predicate device (K250541), maintaining the same fundamental magnetic compression anastomosis technology and intended use. The only modification is in the delivery tools, which were redesigned to consolidate two separate tools into one unified tool that delivers both implants sequentially while improving ease of use.
Transportation Validation and Shipping (ASTM D 4169:2022); Biocompatibility testing per ISO 10993 standards including Cytotoxicity MEM Elution (ISO 10993-5), Sensitization (ISO 10993-10), Intracutaneous Irritation (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), and Material-Mediated Pyrogenicity (ISO 10993-11); Usability testing, human clinical feedback, packaging validation, and simulated use testing.
View the full FDA submission: accessdata.fda.gov